Covid19 VaccineMONITOCOVAGINGNCT04760704
Covid-19 Vaccine Response in Elderly Subjects
An observational study of Covid19 Vaccine, run by University Hospital, Lille at 1 site in France.
Trial summary
The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccine
- What is being tested?
- Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration
- Type of treatment
- Vaccines
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2021to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly persons > 65 years of age residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
Who may be able to join
- Target population.
- Elderly persons > 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
- Male or female resident in an institution for the elderly or in a long-term care unit
- For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.
- Having consented to participate in the study, and willing to comply with all study procedures and its duration
- Socially insured patient
Show all 12Show fewer
- Control population
- Health and medico-social sector professionals aged between 40 and 65 years old for whom a COMIRNATY® anti-SARS-CoV-2 vaccination is indicated as recommended by the HAS.
- Male or female between 40 and 65 years of age included
- For whom consent has been obtained prior to any COMIRNATY® SARS-CoV-2 vaccination.
- Having consented to participate in the study, and willing to comply with all study procedures and its duration
- Socially insured subject
Who cannot join
- Progressive infectious pathology
- Progressive neoplastic pathology (or remission of < 5 years)
- Treatment with long-term corticosteroids or immunosuppressants
- Refuse of consent to vaccination or study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.
The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).
- Conditions
- Covid19 Vaccine
- Being tested
- Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration
- Keywords
- SARS-CoV-2, vaccination, immunosenescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administrationBiological
Specific T cells and specific antibodies assessment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit Receives: Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration | |
| control group | Health and medico-social professionals between 40 and 65 years of age Receives: Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects
Measured: At 3 months after the first vaccine administration
Secondary outcomes (11)
Specific CD4+ and CD8+ T cell response
Comparison of number of anti-S specific CD4+ and CD8+ T cells detected at 3 and 9 months, between elderly and control subjects
Measured: At 3 months and at 9 months after vaccine administration
Total anti-S and neutralizing antibody levels
Comparison of total anti-S and neutralizing antibody levels (to pseudo-viral particles and to live virus) at 3 and 9 months after vaccine administration between elderly and control subjects.
Measured: At 3 months and at 9 months after vaccine administration
Specific immune response according to presence/absence of pre-vaccine antibodies
Comparison of anti-S specific T cells, anti-S total antibody and neutralising antibody levels at 3 and 9 months depending on the presence or absence of pre-vaccine antibodies compatible with previous infection in elderly subjects
Measured: At 3 months and at 9 months after vaccine administration
Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine
Comparison of anti-S-specific total T-cell count, anti-S total antibody levels and neutralising antibody levels 3 months after COVID-19 infection (before any vaccination) and 3 months after vaccination (in subjects who had no COVID-19 before) in elderly subjects
Measured: At 3 months after vaccine administration
Specific immune response according to nutritional status
Correlation between number of anti-S specific T cells, total anti-S antibody and neutralising antibody levels at 3 and 9 months and nutritional status of elderly subjects evaluated according to the Geriatric Nutritional Risk Index (GNRI) in elderly subjects.
Measured: At 3 months and at 9 months after vaccine administration
Correlation between number of T cells, total anti-S antibody and neutralising antibody at 3 and 9 months, and basal levels of proinflammatory cytokines (interleukin-6, TNF-alpha) in elderly subjects
Measured: At 3 months and at 9 months after vaccine administration
Peripheral blood mononuclear cells and serum collection
Sampling and conservation of mononuclear cells and serum before injection, at D21 (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months, in elderly and control subjects.
Measured: before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.
Correlation between number of T cell , total anti-S and neutralizing antibody levels at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
The neutralizing antibody level at 3 and 6 months will be compared to the levels observed during the infection (serologies done systematically, serum available for retro analysis)
Measured: at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Correlation between number of T-cell , total anti-S and neutralizing antibody levels before the booster and 3, 6 and 12 months after the booster (neutralization tests will be done on BA.1 and any variant of interest at the time of testing).
Measured: Before the booster and 3, 6 and 12 months after the booster
Correlation between number of T-cell counts, total anti-S and neutralizing antibody levels within 24-48 hours of a positive PCR (neutralization tests will be done on the variant of interest at the time of testing).
Measured: within 24-48 hours of a positive PCR
Saliva samples
Measured: at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start18 Feb 2021
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 VaccineStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume LEFEVRE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760704
- Sponsor's protocol ID
- 2021_02
- Other IDs
- 2021-A00119-32
- Acronym
- MONITOCOVAGING
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.
- ClinicalTrials.gov ID
- NCT04760704
- Acronym / sponsor ID
- MONITOCOVAGING / 2021_02
- Conditions
- Covid19 Vaccine
- Keywords
- SARS-CoV-2, vaccination, immunosenescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administrationPersons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit |
| control group | – | Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administrationHealth and medico-social professionals between 40 and 65 years of age |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly persons > 65 years of age residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
Key inclusion criteria (12 listed)
- Target population.
- Elderly persons > 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
- Male or female resident in an institution for the elderly or in a long-term care unit
- For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.
- Having consented to participate in the study, and willing to comply with all study procedures and its duration
Key exclusion criteria (4 listed)
- Progressive infectious pathology
- Progressive neoplastic pathology (or remission of < 5 years)
- Treatment with long-term corticosteroids or immunosuppressants
- Refuse of consent to vaccination or study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administrationSpecific T cells and specific antibodies assessment | Biological | Experimental group, control group |
Primary outcome
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Time frame: At 3 months after the first vaccine administration
Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects
11 secondary outcomes
Specific CD4+ and CD8+ T cell response
Time frame: At 3 months and at 9 months after vaccine administration
Total anti-S and neutralizing antibody levels
Time frame: At 3 months and at 9 months after vaccine administration
Specific immune response according to presence/absence of pre-vaccine antibodies
Time frame: At 3 months and at 9 months after vaccine administration
Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine
Time frame: At 3 months after vaccine administration
Specific immune response according to nutritional status
Time frame: At 3 months and at 9 months after vaccine administration
Correlation between number of T cells, total anti-S antibody and neutralising antibody at 3 and 9 months, and basal levels of proinflammatory cytokines (interleukin-6, TNF-alpha) in elderly subjects
Time frame: At 3 months and at 9 months after vaccine administration
Peripheral blood mononuclear cells and serum collection
Time frame: before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.
Correlation between number of T cell , total anti-S and neutralizing antibody levels at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Time frame: at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Correlation between number of T-cell , total anti-S and neutralizing antibody levels before the booster and 3, 6 and 12 months after the booster (neutralization tests will be done on BA.1 and any variant of interest at the time of testing).
Time frame: Before the booster and 3, 6 and 12 months after the booster
Correlation between number of T-cell counts, total anti-S and neutralizing antibody levels within 24-48 hours of a positive PCR (neutralization tests will be done on the variant of interest at the time of testing).
Time frame: within 24-48 hours of a positive PCR
Saliva samples
Time frame: at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LEFEVRE, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 Vaccine, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine (time frame: At 3 months after the first vaccine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.